CMV Antiviral Prevention Strategies in D+R-Liver Transplants ("CAPSIL")

• Status: Completed
• Trial end date: 2018-06-22
• Target enrollment: 0
• Participant gender: All

Summary

This is a trial of preemptive therapy vs. prophylaxis for prevention of Cytomegalovirus (CMV) disease in R-D+ liver transplant patients. Subjects will be randomized within 10 days of transplant to receive in an open label design, either antiviral prophylaxis with valganciclovir, 900 mg orally once daily or preemptive therapy (weekly monitoring for CMV viremia by plasma PCR) for 100 days post-randomization with initiation of oral valganciclovir 900mg orally twice daily at onset of CMV viremia and continued until plasma PCR is negative on two consecutive weekly PCR tests). A minimum of 176 subjects will be enrolled in the study. The study duration is 7 years. The primary objective of this study is to compare prophylaxis versus preemptive therapy using valganciclovir for the prevention of CMV disease in R-/D+ liver transplant recipients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); University of Pittsburgh
• Collaborator: National Institutes of Health (NIH)
• Treatments: Ganciclovir; Valganciclovir

Criteria

Inclusion Criteria:

1. Be > / = 18 years of age.

2. Have negative Cytomegalovirus (CMV) serology (confirmed within 6 months of transplant) and receive a liver from a donor with positive CMV serology (R-/D+).

3. Have received their first orthotopic liver transplant (the transplanted liver may be deceased donor or live donor graft) within 10 days prior.

4. Have absolute neutrophil count > 1000/µL at randomization.

5. - If female, and not postmenopausal or surgically sterile, must have negative pregnancy test (serum or urine) within 48 hours prior to randomization and must also agree to use medically approved method of contraception. Acceptable methods include: barrier method, intrauterine device (hormonal or non-hormonal), oral hormonal contraceptives, abstinence for 100 days after randomization and 3 months after valganciclovir cessation.

-- If male, and has not had a vasectomy, he must agree to practice barrier method of contraception for 100 days after randomization and 3 months after valganciclovir cessation.

6. Subject or legally authorized representative has provided written informed consent.

Exclusion Criteria:

1. Currently enrolled in any interventional trial of an investigational therapeutic agent unless co-enrollment has been approved by study Principal Investigators (PIs) and the DMID prior to enrollment.

2. Have hypersensitivity to acyclovir, ganciclovir or valganciclovir.

3. Be breast-feeding mother.

4. Have known Human immunodeficiency virus (HIV) infection (based on testing performed during the transplant evaluation process).

5. Be undergoing multi organ transplant or have undergone prior organ transplant.

6. Have expected life expectancy of less than 72 hours.